GEMINI UNIVERSAL 5 MM FIBER OPTIC LIGHT CABLE 5.0 MM X 10 FT
Received Sep 6, 2017 · Event occurred May 22, 2017
Report 9610773-2017-00104 · MDR key 6844206
Device
Generic name
Fiber Optic Light Cables And Adaptors
Manufacturer
Smith & Nephew PlcModel number
7205178Catalog number
7205178
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn(s)
- Full thickness (Third Degree) Burn
- Burn(s)
- Full thickness (Third Degree) Burn
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: THE SUSPECT MEDICAL DEVICE WAS RETURNED TO OLYMPUS KEYMED (OKM) WHERE ITS LEGAL MANUFACTURER WAS IDENTIFIED AS SMITH & NEPHEW, NOT OLYMPUS. THEREFORE, THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS. HOWEVER, THE LEGAL MANUFACTURER WILL BE INFORMED.
Additional Manufacturer Narrative
THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem
OLYMPUS WAS INFORMED BY THE LOCAL/NATIONAL COMPETENT AUTHORITY (CA) (B)(6) THAT DURING A THERAPEUTIC KNEE SURGERY PROCEDURE, THE PATIENT SUSTAINED A THIRD-DEGREE BURN OF THE RIGHT LOWER LEG. IT IS SUSPECTED THAT THIS INJURY WAS CAUSED BY THE HOT LIGHT-GUIDE CABLE. HOWEVER, NO FURTHER INFORMATION WAS PROVIDED.